CLINICAL RESEARCH MANAGEMENT OFFICE The Clinical Research Management Office (CRMO) is the shared resource ofthe Kimmel Cancer Center (KCC) that supports physicians, scientists and other staff in the development, implementation, and conduct of clinical trials. The CRMO provides a broad range of services tailored to the specific needs of investigators, the KCC, and consortium partners. These services include supervision of activities related to trial registration and conduct, quality assurance, and monitoring of KCC institutional, pharmaceutical and cooperative group clinical trials. The CRMO also serves as a resource for the KCC community and patients by providing relevant information regarding clinical trial availability. Specific aims of the CRMO include: Orientation of new faculty to KCC, CRMO and (TJU) policies and procedures related to clinical research Facilitate the development of KCC investigator initiated clinical trials Coordinate the preparation and submission of studies for review by the Multidisciplinary Groups (MDG), Clinical Cancer Research Review Committee (CCRRC) and the Thomas Jefferson University Institutional Review Board (IRB) Collect, abstract, maintain and update data specific to patients entered on clinical trials Coordination of study visits and procedures related to clinical trials Assure timely and accurate preparation and submission of all regulatory reviews (e.g. new submissions, amendments, annual reports, safety information, etc. to the IRB and FDA) Serve as a liaison between the TJU IRB, FDA or other regulatory bodies, and KCC investigators Assure accurate entry of patients participating in KCC clinical trials in a centralized database Assist in the maintenance of an accurate shared drive repository for complete protocols and informed consents. To improve easy access to viewing clinical trials Participate in the integration and activation of OnCore clinical trials management system Assure appropriate integration of consortium partners into the conduct of clinical research